A study to evaluate the effect of ticagrelor in reducing the number of days with pain in patients with sickle cell disease.

A randomised, double-blind, double-dummy, parallel-group, multicenter, phase IIb study to evaluate the effect of ticagrelor 10 mg and 45 mg bid versus placebo in reducing the number of days with pain in young adults with sickle cell disease. - Young Adult SCD Study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-005420-10-GB

Enrollment

180

Registered

2015-07-20

Start date

2015-09-22

Completion date

Unknown

Last updated

2019-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Investigating the number of days of pain in SCD patients.

Interventions

Product Name: Ticagrelor Product Code: AZD6140 Pharmaceutical Form: Tablet INN or Proposed INN: Ticagrelor CAS Number: 274693-27-5

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Male and female young adults aged = 18 to = 30 years inclusive, diagnosed with homozygous sickle cell (HbSS) or sickle beta-zero-thalassaemia (HbS/ß0). 2. If treated with an anti-sickling agent such as hydroxyurea, dose must be stable for 3 months before enrolment. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 180 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Patients should have low risk for haemorrhagic events, no significant hepatic impairment or renal failure requiring dialysis and low risk of bradycardic events. 2. No concomitant oral or intravenous therapy with strong CYP3A4 (cytochrome) inhibitors, CYP3A4 substrates with narrow therapeutic indices, or strong CYP3A4 inducers. 3. No surgical procedure planned to occur during the study. 4. Patients who are currently pregnant or breastfeeding or planning to become pregnant during the study. 5. Patients who have known hypersensitivity or contraindication to ticagrelor.

Design outcomes

Primary

Measure	Time frame
Main Objective: The effectiveness of two different doses of ticagrelor versus placebo in reducing the number of days with pain due to sickle cell disease.; Secondary Objective: The effectiveness of two different doses of ticagrelor versus placebo in reducing the intensity of pain due to sickle cell disease. The effectiveness of two different doses of ticagrelor versus placebo in reducing the use of analgesics due to sickle cell disease. ;Primary end point(s): Number of days with pain due to sickle cell disease.;Timepoint(s) of evaluation of this end point: Baseline to end of treatment (16 weeks).	—

Measure

Time frame

Main Objective: The effectiveness of two different doses of ticagrelor versus placebo in reducing the number of days with pain due to sickle cell disease.; Secondary Objective: The effectiveness of two different doses of ticagrelor versus placebo in reducing the intensity of pain due to sickle cell disease. The effectiveness of two different doses of ticagrelor versus placebo in reducing the use of analgesics due to sickle cell disease. ;Primary end point(s): Number of days with pain due to sickle cell disease.;Timepoint(s) of evaluation of this end point: Baseline to end of treatment (16 weeks).

—

Secondary

Measure	Time frame
Secondary end point(s): Intensity of pain due to sickle cell disease and days of analgesic use.;Timepoint(s) of evaluation of this end point: Baseline to end of treatment (16 weeks).	—

Countries

France, Italy, Jamaica, Kenya, Turkey, United Kingdom, United States

Contacts

Public ContactInformation Center

AstraZeneca

18772409479

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026